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NCT Number: NCT06662461

Ultrasound Guided Block of Stellate Ganglion Versus Greater Occipital Nerve in Resistant Migraine and Correlation to Calcitonin Gene Related Peptide

To investigate the efficacy of Ultrasound guided Stellate Ganglion block in chronic resistant migraine patients in comparison to Greater Occipital Nerve Block correlating its effect to serum CGRP level.

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

40 Patients diagnosed with Chronic resistant migraine to 2 anti-migraine drugs for 3 months will be evaluated for inclusion and exclusion. Eligible patients with resistance or intolerability to 2 drugs or more will be classified into two groups by using simple randomization methods through Using a computer-generated random number sequence.

Each group will contain 20 patients one group will undergo ultrasound guided bilateral Greater Occipital nerve Block and the other group will undergo ultrasound guided bilateral Stellate Ganglion Block

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Individuals diagnosed with chronic resistant migraine after using or intolerability to 2 or more of anti-migraine drugs for at least 3 months

Exclusion criteria

  • Patients with a space-occupying lesion.
  • Coagulation disorders.
  • Systemic or local infection and drug allergies.

Treatment and study plan

ultrasound guided Greater occipital nerve block

Procedure

Patients will be positioned in a prone position with their neck slightly flexed.

The trapezius , semispinalis, obliqus capitis muscles will be revealed on short-axis view.

A 25- or 21 gauge is used, with puncture point 1-1.5 cm away from the ultrasound probe.

Under the guidance of the ultrasound, GOB will performed by injection using 40 mg triamcinolone and 1ml of 2% lidocaine.

Ultrasound guided Stellate ganglion block

Procedure

Patients are positioned in a lateral position with their necks slightly hyperextended. Assisted by ultrasound imaging equipment the C7 level is confirmed. The thyroid gland, carotid artery, compressible internal jugular vein, vertebral artery, brachial plexus and the oval-shaped structure of the longus collis muscle are revealed on this short-axis view.

A 25- or 21 gauge is used and the puncture point is 1-1.5 cm away from the ultrasound probe The tip of the needle reach the surface of the longus collis muscle and the 5 o'clock position of the carotid artery. Under the guidance of the ultrasound, SGB is performed by injection using 40 mg triamcinolone and 1ml of 2% lidocaine.

Primary outcomes

  1. Changes in Headache impact test (HIT-6)

    Time frame: 3 months

    Each of the six questions of the HIT-6 receives a score from 6-13. The final HIT-6 score can range from 36 to 78. A higher score indicates more disability due to headache.

  2. changes in Migraine disability assessment test (MIDAS)

    Time frame: 3 months

    The MIDAS questionnaire is based on five disability questions that focus on lost time in three domains: school work or work for pay; household work or chores; and family, social, and leisure activities. The scoring is:

    0-5: little or no disability 6-10: mild disability 11-20: moderate disability 21+: severe disability

  3. changes in Numeric Rating Scale (NRS)

    Time frame: 3 months

    a score used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"

Secondary outcomes

  1. Changes in circulating CGRP level

    Time frame: 1 month

Study contacts

Contact information is provided by the study sponsor or research team.

Mai Fathy Ass.Prof.Mai Fathy

CONTACT

[email protected]

+2001023868846

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Collaborators

  • Ahmed Mohamed Abdelfattah Sharawy
  • Ahmed Mohamed ElSadek
  • Mohamed Amir Tork
  • Noha Lotfy Soliman
  • Sherien Mohamed Farag

Registry information

Official study title

Efficacy of Ultrasound Guided Block of Stellate Ganglion Versus Greater Occipital Nerve in Chronic Resistant Migraine Patients and Its Correlation to Calcitonin Gene Related Peptide (CGRP)

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Oct 29, 2024
Registry last updated
Oct 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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